BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEMHEART

    MDR report key: 888354 · Received July 23, 2007

    Report

    Report Number
    888354
    Event Type
    Injury
    Date Received
    July 23, 2007
    Date of Event
    May 8, 2007
    Report Date
    July 23, 2007
    Manufacturer
    CARDIAC ASSIST, INC
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED FROM AN OUTSIDE HOSPITAL IN CARDIOGENIC SHOCK, STATUS POST (S/P) MI TO THE CATHERIZATION LABORATORY. STENTS WERE PLACED, IABP AND TANDEM VENTRICULAR ASSIST DEVICE (VAD) PLACED. ABOUT 18 HRS AFTER VAD WAS PLACED THE IABP ABRUPTLY ALARMED AND STOPPED. THE PATIENT WAS ALREADY ON PRESSORS AND IABP (ALONG WITH THE VAD). THE RN OBSERVED "CONSOLE WON'T RUN. THE CONSOLE WAS SWITCHED TO BACK-UP, MULTIPLE ATTEMPTS TO RESTART UNSUCCESSFUL." THERE WERE EXPERT CLINICIANS AT THE BEDSIDE. THE COMPANY WAS CONTACTED FOR ASSISTANCE TO TROUBLESHOOT. THE PATIENT BECAME LESS STABLE, REQUIRING INCREASED VASOPRESSORS. WHEN THE VAD COULD NOT BE RESTARTED WITHIN 15 MINUTES BY TROUBLESHOOTING AT THE BEDSIDE, THE PATIENT WAS REBOLUSED WITH HEPARIN, THE VAD WAS CLAMPED AND DEVICE WAS DECANNULATED AND REMOVED. SUBSEQUENTLY THE PATIENT REMAINED ON A VENTILATOR, IABP, AND PRESSOR SUPPORT. THE PATIENT WAS STABILIZED OVER SEVERAL DAYS, EVENTUALLY WEANING FROM SUPPORT. THE PATIENT EVENTUALLY WAS DISCHARGED TO REHABILITATION WITH NO NEUROVASCULAR SEQUELAE 14 DAYS LATER.AFTER ANALYSIS OF FAILED DEVICE BY MANUFACTURER (CARDIAC ASSIST) ANY HIGH FLOW READINGS SEEN IN THE CATH LAB ON INSERTION WILL PROMPT IMMEDIATE SWAP OUT OF THE VAD DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANDEMHEART PUMP, VENTRICULAR ASSIST DSQ CARDIAC ASSIST, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention CARDIAC DRUGS